ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS:. The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria.
CLINICAL PHARMACOLOGY SECTION.
CLINICAL PHARMACOLOGY:. Hydrocortisone acetate has anti-inflammatory, antipruritic and vasoconstrictive properties. While the mechanism of anti-inflammatory activity is unclear, there is evidence to suggest that recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in humans. Iodoquinol has both antifungal and antibacterial properties.Pharmacokinetics: The extent of percutaneous absorption of topical steroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Hydrocortisone acetate can be absorbed from normal intact skin. Inflammation and/or other inflammatory disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, hydrocortisone acetate is metabolized in the liver and most body tissue to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with very small proportion of unchanged hydrocortisone acetate. There are no data available regarding the percutaneous absorption of iodoquinol; however, following oral administration, 3-5% of the dose was recovered in the urine as glucuronide.
CONTRAINDICATIONS:. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
DESCRIPTION:. Each gram contains 19 mg of hydrocortisone acetate and 10 mg iodoquinol in vehicle consisting of: aloe vera powder, amino methylpropanol 95%, benzyl alcohol, carbomer, citric acid anhydrous, D&C yellow 10, FD&C blue 1, glycerin, glyceryl polymethacrylate, magnesium aluminum silicate, palmitoyl oligopeptide, PPG-20 methyl glucose ether, propylene glycol, purified water and SD Alcohol 40B.Hydrocortisone acetate is an anti-inflammatory and antipruritic agent. Chemically, hydrocortisone acetate is [Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-ss)-] with the molecular formula (C 23H 32O 6) and is represented by the following structural formula: Iodoquinol is an antifungal and antibacterial agent. Chemically, Iodoquinol is [5,7-diiodo-8-quinolinol] with the molecular formula (C 9H 5I 2NO) and is represented by the following structural formula: structure1.jpg. structure2.jpg.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION:. Apply to affected area(s) three to four times per day or as directed by physician.
HOW SUPPLIED SECTION.
HOW SUPPLIED:. This product is supplied in the following size(s): Carton, NDC 52191-352-30, containing 30 sachets (Net Wt. g each). Each sachet is unit of use discard after opening. To report serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Bowyn Labs, LLC 13785 Research Blvd., Suite 125 Austin, TX 78750 827515 v3 Rev. 05/2017.
INDICATIONS & USAGE SECTION.
INDICATIONS:. Based on review of related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: Possibly Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
STORAGE AND HANDLING SECTION.
STORAGE:. Store at 20C to 25C (68F to 77F), excursions permitted between 15C to 30C (between 59F to 86F). Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinetic temperature does not exceed 25C (77F); however, such exposure should be minimized.NOTICE: Protect from freezing and excessive heat.
WARNINGS AND PRECAUTIONS SECTION.
WARNINGS: KEEP OUT OF REACH OF CHILDREN.. PRECAUTIONS: FOR EXTERNULLL USE ONLY. NOT FOR OPHTHALMIC USE.Avoid contact with eyes, lips and mucous membranes.Information for Patients: If irritation develops, the use of this product should be discontinued and appropriate therapy instituted. Staining of the skin, hair and fabrics may occur. Not intended for use on infants or under diapers or occlusive dressings. If extensive areas are treated or if the occlusive dressing technique is used, the possibility exists of increased systemic absorption of the corticosteroid, and suitable precautions should be taken. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on child being treated in the diaper area, as these garments may constitute occlusive dressings. Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield false positive result if iodoquinol is present in the diaper or urine. Prolonged use may result in overgrowth of non-susceptible organisms requiring appropriate therapy.Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been performed with iodoquinol. Pregnancy:Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to pregnant woman. This product should be used by pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.